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PSR Form 3 and 4 Output Is Inconsistent Between E2BR2 and E2BR3 (Doc ID 2467847.1)

Last updated on DECEMBER 01, 2020

Applies to:

Oracle Argus Safety Japan - Version 8.1.1 and later
Information in this document applies to any platform.

Symptoms

When a case is having 2 products and events and they are having the following reportability;
Product-A / Event-X / Serious --- Causality=Y / Unlisted
Product-A / Event-Y / Serious --- Causality=N / Unlisted
Product-B / Event-X / Serious --- Causality=N / Unlisted
Product-B / Event-Y / Serious --- Causality=Y / Unlisted
and E2B R2 or R3 is submitted, and PSR is generated including the submitted E2B report of the case, 
the printed Event on PSR Form-3 and Form-4 is inconsistent between when the submitted E2B was R2 and R3.

Submitted E2B was R2 --- only Event-X is printed on PSR Form-3 and 4.
Submitted E2B was R3 --- both Event-X and Y are printed on PSR Form-3 and 4.

 

STEPS TO REPEAT:
======================
[A] Submitted E2B was R3:
1) Create 2 console products.
Product-A
...|--License-A --- Japan MKT license
Product-B
...|--License-B --- Japan MKT license
2) Create a new Domestic Spontaneous case at Case Actions >> New by
Product = License-A
Event = Event-X
3) Open case form for the created case and go to Case Form Products.
Add a case product by License-B.
4) Go to Case Form >> Events >> Event.
Add an event Event-Y.
Set both events as serious (MMedically Significant = Y).
5) Go to Case Form >> Events >> Event Assessment.
Set Listedness = Unlisted for all product and event combinations.
Set Causality as follows.
Product-A / Event-X --- Causality=Y
Product-A / Event-Y --- Causality=N
Product-B / Event-X --- Causality=N
Product-B / Event-Y --- Causality=Y
6) Go to Case Form >> Analysis >> Analysis.
Enter Narrative and other comment fields.
7) Go to Case Form >> Analysis >> PMDA Info >> General.
Enter License Category and Reporting Category for License-A.
8) Go to Case Form >> Analysis >> PMDA Info >> Comments.
Enter comments in comment fields for License-A.
9) Go to Case Form >> Regulatory Reports.
Schedule E2B R3 for PMDA for License-A.
10) Generate and transmit the E2B R3 for PMDA.
11) Submit the E2B R3 for PMDA by importing ACK.
12) Create a new PSR and configure it to include the submitted E2B R3 for PMDA for License-A.
Agency = only the same PMDA R3 agency of the submitted E2B R3 for PMDA for License-A.
Product = only Product-A.
Schedule period = date includes the E2B R3 report's submitted date.
Set the rest parts of PSR Config to include the submitted E2B R3 for PMDA for License-A.
13) Print the PSR as Draft.
14) After the PSR is generated, open the PSR.
--->Form-3 and Form-4 prints Event-X and Event-Y.

[B] Submitted E2B was R2:
1) Copy the case used at the previous test with E2B R3 into a new copied case.
The copied new case is having the same Case Products and Case Events.
2 products and 2 events.
Product-A / Event-X --- Causality=Y
Product-A / Event-Y --- Causality=N
Product-B / Event-X --- Causality=N
Product-B / Event-Y --- Causality=Y
2) Remain all the case data as the source case.
3) Go to Case Form >> Regulatory Reports.
Schedule E2B R2 for PMDA for License-A.
4) Generate and transmit the E2B R2 for PMDA.
5) Submit the E2B R2 for PMDA by importing ACK.
6) Copy the PSR used at the previous test with E2B R3 into a new copied PSR.
Agency = change to only the same PMDA R2 agency of the submitted E2B R3 for PMDA for License-A.
Product = only Product-A.
Schedule period = date includes the E2B R2 report's submitted date.
Set the rest parts of PSR Config to include the submitted E2B R2 for PMDA for License-A.
7) Print the PSR as Draft.
8) After the PSR is generated, open the PSR.
--->Form-3 and Form-4 prints Event-X only.



Cause

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In this Document
Symptoms
Cause
Solution
References


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